EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Study information

Scientific title

Acronym

Study hypothesis

Nicotine replacement therapy (NRT) taken for one month before and two months after smoking cessation will be more effective than usual care i.e. NRT for two months after the quit date.

Please note that as of 09/02/09 this record was updated to include an amended anticipated end date. The initial anticipated end date was 30/06/2011.

Ethics approval

Added 09/02/2009:1. The Ethics Board of the Association des médecins du canton de Genève (AMG) gave approval on the 15th January 2004 2. The Ethics Board of the Faculty of Biology and Medicine, University of Lausanne gave approval on the 20th April 2006

Trial type

Patient information sheet

Condition

Intervention

Nicotine gum (4 mg) for one month before and two months after quitting smoking. The control group will receive similar gums, but only after they quit smoking, for 2 months. No placebos will be used.

Intervention type

Drug

Phase

Not Specified

Drug names

Nircotine replacement therapy (NRT)

Primary outcome measures

1. Smoking status at the target quit date, and 2, 12 and 60 months thereafter. We will use the criterion recommended by the U.S. Food and Drugs Administration (FDA) to assess outcome in smoking cessation studies: not having smoked even one puff of tobacco during the previous 4 weeks, and the criterion recommended in a recent guideline: not having smoked even one puff of tobacco in the previous 7 days. At 12 months only, smoking abstinence will be verified by saliva cotinine and, if positive, by expired carbon monoxide.2. Tobacco withdrawal symptoms at the target quit date and 2 months thereafter3. Utilisation of nicotine gums at the target quit date and 2 months thereafter (number of gums per day and duration of use)

Secondary outcome measures

At 12 months, we will use as secondary outcome the recently recommended criterion of 6 months of continuous abstinence.Other outcomes:1. Quit attempts (number and duration)2. Motivation to quit smoking3. Confidence in ability to quit smoking, self-efficacy4. Cigarette consumption5. Level of dependence on cigarettes, assessed with the CDS-12 test6. Side-effects of NRT7. Attitudes towards NRT, in particular perception that NRT is dangerous

Overall trial start date

01/09/2005

Overall trial end date

31/12/2009

Reason abandoned

Eligibility

Participant inclusion criteria

1. Smokes 15+ cigarettes per day2. Lives in the Swiss cantons of Geneva or Vaud3. Daily smoker for at least 3 years4. Aged 18 years or more, either sex5. Seriously intends to quit smoking in the next two months6. Willing to use 4 mg nicotine gums for one month before and two months after smoking cessation7. Willing to postpone smoking cessation until one month after enrolment in the study8. Commits to take part in all follow-up procedures, including if he/she is attributed to the control group9. Declares to understand and accept the control-group procedure10. Signs the informed consent form11. Has access to internet at home or at work and provides a valid e-mail address12. Provides a telephone number13. Provides a health status questionnaire signed by a physician and by the participant

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

860 (amended as of 09/02/2009 = 314 participants)

Participant exclusion criteria

1. Current use of NRT or bupropion2. Pregnancy, lactation or planned pregnancy3. Unstable angina pectoris4. Myocardial infarction or cerebral vascular accident within the last 3 months5. Under psychiatric care or medication that might interfere with the trial6. Alcohol or other drug problem that might interfere with the trial7. Having a mouth pathology, and/or dental problem that might interfere with gum use

Recruitment start date

01/09/2005

Recruitment end date

31/12/2009

Locations

Countries of recruitment

Switzerland

Trial participating centre

IMSP CMU
Geneva 4
CH-1211
Switzerland

Sponsor information

Organisation

University of Geneva - Institute of Social and Preventive Medicine (Switzerland)